Information: Health Canada and Drug Safety

The Government's priority is to allow access to drugs for therapeutic purposes while protecting individuals and communities against the harm caused by prescription drug diversion and abuse.

Addressing prescription drug abuse involves many stakeholders in the health care system - from federal, provincial and territorial governments, to prescription drug manufacturers and distributors, to physicians and other health care providers.

Health Canada is the Ministry responsible for approving pharmaceutical drugs for sale in Canada. The Department also regulates controlled substances, which can alter mental processes and that may produce harm to health and to society when diverted or abused. The Food and Drugs Act and the Controlled Drugs and Substances Act work together to get drug treatments into the hands of those Canadians that truly need them and keep them out of the hands of those who don't. This fact sheet provides information on these roles.

Drug approvals

Market authorization for drugs would be issued only if Health Canada determines that the drug demonstrates safety, efficacy and quality.

The manufacturer must provide evidence that the benefits of the drug outweigh the risks under recommended conditions of use.

If a drug is approved that has potential for abuse, Health Canada would work with its partners to communicate the risks of the medication to doctors and patients in order to help minimize the potential for abuse. There are also controls in place under the Controlled Drugs and Substances Act to minimize the diversion and abuse of prescription drugs that contain controlled substances.

In addition, Health Canada remains vigilant in performing post-market surveillance of health products and in communicating new safety information.

Controlling prescription drugs

The Controlled Drugs and Substances Act (CDSA) and its regulations contain control measures intended to minimize the diversion and abuse of controlled substances and prescription drugs that contain them (e.g., drugs such as Percocet and Oxycontin which contain the controlled substance oxycodone), by outlining requirements for producers, health care practitioners, pharmacists and others. For example:

All individual and business entities authorized to conduct activities with controlled substances are subject to security, record-keeping and reporting requirements as set out in the various regulations made under the CDSA. Facilities where controlled substances are handled can be inspected for compliance with the CDSA and its regulations.

Practitioners, pharmacists and hospitals must maintain records indicating receipt and sale of certain controlled substances, including narcotics, and take reasonable steps to protect controlled substances against loss or theft.

Licensed dealers, practitioners, pharmacists and hospitals must report the loss and theft of a controlled substance to the Minister of Health within 10 days of discovery.

Health Canada, in certain circumstances, has the authority to suspend or revoke a dealer's licence, or refuse to issue, amend, or renew such a licence.

Health Canada also has the authority, in certain circumstances, to issue a notice which, in effect, restricts a practitioner from prescribing controlled substances or a pharmacy from filling said prescriptions for products containing controlled substances.

This complements the efforts of provincial and territorial governments to address prescription drug abuse, which include establishing training requirements, setting scopes of practice, monitoring prescription practices and other programs.

First Nations and Inuit Health

The Government of Canada takes the health and safety of all citizens very seriously and remains vigilant in its efforts to address the risk of diversion of potential drugs of abuse from nursing stations located on First Nations reserves.

Health Canada helps to prevent the diversion of drugs of abuse from Nursing Stations in First Nation communities by enforcing strict control measures, tight inventory management, physical security building standards, and the regular conduct of audits by Health Canada personnel.

The Government of Canada is committed to continued enforcement of stringent policies and procedures for the safeguarding of potential drugs of abuse at nursing stations located on reserves.